510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K901225Substantially Equivalent

Life Shield (Disposable Pressure Infusor)

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901225 is the FDA 510(k) clearance record for LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR), a class I device, cleared for Abbott Laboratories on under FDA product code KZD (Infusor, Pressure, For I.V. Bags). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K901225.

Clearance record

Decision date
Received
(162 days to decision)
Product code
KZD Infusor, Pressure, For I.V. Bags
Regulation
21 CFR 880.5420
Device class
Class I
Review panel
General Hospital
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
Third party review
No

Clearances, product code KZD

Trailing 12 months

FDA records hold no clearances under product code KZD in the trailing twelve months.

FDA records show no clearances under product code KZD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260